Abstract
The present clinical study was designed to evaluate the efficacy, pharmacokinetics and safety of a new 10% liquid intravenous immune globulin in patients with primary immunodeficiency diseases. Sixty-one adults and children with primary immuno-deficiency diseases received doses of 300-600 mg/kg body weight every 21-28 days for 12 months. No validated acute serious bacterial infections were reported. The 95% confidence interval for the annualized rate of acute serious bacterial infections (primary endpoint) was 0-0.060. A total of four predefined validated other bacterial infections commonly occurring in primary immunodeficiency disease subjects were observed; none were serious, severe or resulted in hospitalization. The median elimination half-life of IgG was 35 days. Median total IgG trough levels varied from 9.6 to 11.2 g/L. Temporally associated adverse experiences were determined for 72 h after each infusion and the most common adverse experience was headache, which was associated with 6.9% of infusions. The study met the primary endpoint for efficacy and demonstrated excellent tolerability of the new 10% liquid intravenous imunoglobulin preparation.
Original language | English (US) |
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Pages (from-to) | 388-395 |
Number of pages | 8 |
Journal | Journal of Clinical Immunology |
Volume | 26 |
Issue number | 4 |
DOIs | |
State | Published - Jul 2006 |
Keywords
- Efficacy
- IGIV
- Immune globulin
- Pharmacokinetics
- Primary immunodeficiency
- Safety
ASJC Scopus subject areas
- Immunology and Allergy
- Immunology